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EC number: 300-346-5 | CAS number: 93925-43-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 May 2012 - 29 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted in accordance with the standardised testing guidelines OECD 429, and EU Method B.42, and in accordance with GLP with no deviations thought to affect the quality of the presented data. The study was reported to a high standard, sufficient to assess the reliability of the data presented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- with exception of determining the homogeneity, concentration and stability of the test material formulation. The test material was formulated within two hours of being applied to the test system and was assumed to be stable for this duration.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dioctyltin oxide
- EC Number:
- 212-791-1
- EC Name:
- Dioctyltin oxide
- Cas Number:
- 870-08-6
- IUPAC Name:
- dioctyl(oxo)stannane
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Di-n-octyltin oxide
- Physical state: white solid
- Storage conditions: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15 - 23 g
- Housing: Individually
- Diet: ad libitum
- Water: Mains tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours darkness
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5, 10 or 25 % w/w
- No. of animals per dose:
- Animals were tested in groups of four.
- Details on study design:
- RANGE FINDING TESTS: a preliminary screening test was performed on one mouse. The mouse was treated by daily application of 25 µL of the test material at a maximum attainable concentration of 25 % w/w in propylene glycol, to the dorsal surface of each ear for three consecutive days. The mouse was observed twice daily on days 1, 2 and 3 and once daily on days 4, 5 and 6. Local skin irritation was scored daily according to the scale outlined in the field “Any other information on materials and methods incl. tables”. Any signs of toxicity, if present, were also recorded.
The thickness of each ear was measured using an Oditest micrometer pre-dose on day 1, post dose on day 3 and again on day 6. Any changes in ear thickness were noted.
- Compound solubility: 25 % w/w was selected as the highest dose investigated in the main test, reflecting the maximum attainable concentration of test material in vehicle. The vehicle was chosen as it produced the highest concentration of test material that was suitable for dosing.
TREATMENT PREPARATION AND ADMINISTRATION: Main test
Approximately 25 µL of 5 %, 10 % or 25 % w/w preparation of the test material in propylene glycol was applied using an automatic micropipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using propylene glycol alone. The procedure was repeated daily for 3 consecutive days.
Five days after the first application, all the animals were injected, via the tail vein, with approximately 250 µL of phosphate buffered saline (PBS) containing approximately 80 µCi/mL of 3H-methyl thymidine with a specific activity of 2.0 Ci/mmol (total dose 20 µCi per mouse). Approximately 5 hours later, the animals were humanely killed by carbon dioxide asphyxiation. The draining aurcular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a container of PBS.
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze. The cell suspensions were then washed twice times by centrifugation with approximately 10 mL of PBS. The cells suspensions were pelleted again and resuspended in approximately 3 mL of 5 % w/v trichloroacetic acid (TCA) , and precipitated overngiht (approximately 18 hours) at 4 °C. The samples were again pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1 mL of TCA. The lymph node suspensions were transferred to scintillation vials and 10 mL of scintillant (Optiphase) was added prior to β-scintillation counting using a Packard Tri-Carb 2500TR Liquid Scintillation counter.
CRITERIA USED TO CONSIDER A POSITIVE RESPONSE:
The results are expressed as disintegrations per minute (dpm) value per lymph node for each group. The activity of each test group is then divided by the activity of the vehicle control group to give a test:control ratio for each concentration. The criterion for a positive response is that one or more concentrations of the test material should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. A test material which does not fulfil the above criterion is designated as unlikely to be a sensitiser. - Positive control substance(s):
- other: phenylacetaldehyde (90 %) as a solution in propylene glycol at a concentration of 2.5 % v/v
Results and discussion
- Positive control results:
- The application of phenylacetaldehyde at concentrations of 2.5 % v/v in propylene glycol resulted in a greater than 3-fold increase in isotope incorporation. Therefore, phenylacetaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The stimulation index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group, is presented in table 2 in 'Any other information on results incl. tables'. The application of the test substance at concentrations of 5 %, 10 % and 25 % w/w in propylene glycol resulted in an isotope incorporation which was less than 3-fold at all three concentrations. Consequently, the test material was designated as unlikely to be a sensitiser under the conditions of the test.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The pooled disintegrations per minute, disintegrations per minute per lymph node and stimulation index are presented in table 2 in 'Any other information on results incl. tables'. The test material is designated as unlikely to be a sensitiser under the conditions of the test.
Any other information on results incl. tables
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% w/w) in vehicle |
dpm |
dpm/node* |
stimulation index # |
Result |
Vehicle |
7746.32 |
968.29 |
na |
na |
5 |
7152.44 |
894.06 |
0.92 |
negative |
10 |
6866.45 |
858.31 |
0.89 |
negative |
25 |
13714.73 |
1714.34 |
1.77 |
negative |
dpm = Disintegrations per minute
* Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
# Stimulation index of 3.0 or greater indicates a positive result
na = not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the isotope concentration was less than three-fold at all test concentrations and therefore, the test material is considered to be unlikely to be a skin sensitiser. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin sensitisation potential of the test material was determined in accordance with the standardised guidelines OECD 429 and EU Method B.42 using the mouse Local Lymph Node Assay. The test material was applied as a 5 %, 10 % or 25 % w/w preparation in propylene glycol. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. The isotope concentration induced by the test material was less than three-fold at all test concentrations and therefore the test material is considered to be unlikely to be a skin sensitiser.
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